Clinical trial · Interventional
Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.
A Phase 2 Pilot Study of the Efficacy and Safety of Nivolumab and Ipilimumab in T1aN0M0 Renal Cell Carcinoma Patients Ineligible for Surgical Treatment.
NCT04134182CI-TRIAL-00049112unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this Phase 2 study is to evaluate the efficacy and safety of nivolumab, an anti-PD-1 antibody, and ipilimumab, an anti-CTLA-4 antibody, in T1aN0M0 clear-cell RCC patients ineligible for surgical treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ipilimumab | Drug | Ipilimumab | ALIAS |
| Nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Nivolumab + Ipilimumab
- description
- Patients will receive a combination of ipilimumab, followed by nivolumab for 16 weeks.
- interventionNames
- Drug: Nivolumab
- Drug: Ipilimumab
Primary outcomes (1)
- measure
- Complete Response Rate
- timeFrame
- 16 weeks
- description
- percentage of patients with localized RCC who have no tumor in kidney
Secondary outcomes (4)
- measure
- Objective response rate
- timeFrame
- 16 weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Cytologically proven clear-cell RCC 2. CT-confirmed measurable primary tumor less than 4 cm and no evidence of extranodal metastatic disease (T1aN0M0) 3. Inability to perform surgery for any reason (functional single kidney with a central, high-complexity RCC, high risk of nephrectomy and dialysis, patients with complex coagulation disorders, etc.) or preference of patient is to have no surgery for any reason 4. No contradictions to nivolumab and ipilimumab 5. Age 18 or older 6. Written informed consent Exclusion Criteria: 1. prior treatment for RCC 2. pregnant or nursing 3. history of serious hypertension, cardiac arrhythmia, congestive heart failure, angina pectoris, or another severe cardiovascular disease (i.e., New York Heart Association class III or IV) 4. evidence of metastatic disease 5. local and/or systemic infections requiring antibiotics within 28 days prior to study entry 6. other malignancy
References
Publications (0)
Data not yet available
No reference posted for this study.